Tracking the International Effort to Keep Clinical Trials for Non-COVID-19 Treatments Moving
Recently, public attention has been captured by the progress of medical treatments and vaccines against COVID-19, which are currently going through clinical trials (categorized into phases 1, 2 and 3).1
Regulatory agencies in the U.S. and other countries tasked with reviewing and approving these and other medical products have been issuing guidelines and Q&A documents to facilitate their expedited development.2
At the same time, medical products for conditions other than COVID-19 have faced significant headwinds with subject recruitment and retainment and the overall conduct of clinical trials.3
Scientists across government agencies, academia and industry are therefore exploring new ways to continue this much-needed work. Possible adjustments range from behavioral and physical modifications, for example, as recommended by the following regulatory agencies:
- Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials (U.S. National Institutes of Health and National Cancer Institute)
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (U.S. Food and Drug Administration)
- Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic (European Commission)
- Guidance for Medicine Developers and Companies on COVID-19 (European Medicines Agency)
Further, as explained in the following publications, others have proposed new statistical solutions:
- Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency (FDA Guidance, June 2020)
- Adaptive Designs in Clinical Trials: Pros and Cons, COVID-19 Research, and Probability Theory (Trial Site News, May 2020)
- Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19 (Taylor & Francis Online, July 2020)
- Pooling Data From Individual Clinical Trials in the COVID-19 Era (JAMA Network, August 2020)
For additional information on these topics or for help with related regulatory issues, please contact Dr. Lana Lyapustina at Faegre Drinker.
- Vaccines and therapeutics trackers:
- Regulatory advice for medical product developers:
- U.S. Food and Drug Administration
- European Medicines Agency
- U.K. Medicines and Healthcare Products Regulatory Agency
- Brazil's Anvisa
- Russia’s Roszdravnadzor
- India’s Central Drug Control and Standards Organization
- China’s National Medical Products Administration
- Australia’s Therapeutic Goods Administration
- South African Government
- Trackers of clinical trial disruptions:
The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.
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